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tirapazamine

Phase 3

Head and Neck Neoplasms | Small molecule | Oncology |Sanofi|Trials Updated: May 26, 2016

tirapazamine development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Feb 2004

tirapazamine target and mechanism

ModalitySmall molecule

Also known as tirapazamine (SR259075), SR259075

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment1,178

FDA Designations

No designations recorded

tirapazamine clinical trials

tirapazamine · 3 trials · 3 indications

Phase 3 3
NCT00174837TRACE: Tirapazamine-Radiation And Cisplatin EvaluationHead and Neck Squamous Cell Carcinoma
COMPLETED317 Analytics
NCT00094081Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck CancerHead and Neck Neoplasms
COMPLETED861 Analytics
NCT00017459Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung Cancer
COMPLETED- Analytics
PHASE3COMPLETED
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Head and Neck Squamous Cell CarcinomaUnlock trial analytics
PHASE3COMPLETED
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
Head and Neck NeoplasmsUnlock trial analytics
PHASE3COMPLETED
Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival
Study period
Overall survival.

Secondary Endpoints

Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Study period
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Study period
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tirapazamine + CisplatinEXPERIMENTAL -
CisplatinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
TirapazamineDRUGin combination with cisplatin and concomitant radiation
CisplatinDRUGwith concomitant radiation
tirapazamine (SR259075)DRUG -
Radiation TherapyPROCEDURE -
vinorelbine tartrateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. * Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease). * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Absolute ...

Countries:United StatesArgentinaAustraliaCanadaChileFranceGermanyHong KongHungaryItalyNew ZealandPolandSingaporeSouth AfricaSpainSwitzerlandTaiwan
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Frequently asked questions about tirapazamine

What is tirapazamine used for?

Tirapazamine has been studied in head and neck neoplasms, head and neck squamous cell carcinoma, and lung cancer. It is an oncology small molecule developed by Sanofi. It is investigational and has not been approved for these indications. Clinical development reached Phase 3, and the trials testing it in these cancer types are completed.

Who makes tirapazamine?

Tirapazamine is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the drug in head and neck cancer and in non-small cell lung cancer. The company is the developer associated with the tirapazamine trials.

What phase is tirapazamine in?

Tirapazamine reached Phase 3 clinical development. Three Phase 3 trials were conducted in head and neck squamous cell carcinoma, head and neck neoplasms, and non-small cell lung cancer, and all are completed. Tirapazamine is investigational and is not an approved therapy.

What clinical trials is tirapazamine in?

Tirapazamine was evaluated in Phase 3 trials including NCT00174837, the TRACE study of tirapazamine, radiation, and cisplatin in head and neck squamous cell carcinoma, and NCT00094081, which tested concomitant radiation and cisplatin with and without tirapazamine in advanced head and neck cancer. NCT00017459 studied cisplatin plus vinorelbine with or without tirapazamine in stage IIIB or IV non-small cell lung cancer.

Is tirapazamine the same as SR259075?

Yes, tirapazamine is also known as SR259075. SR259075 is an alternative designation used for the same investigational oncology small molecule. Readers searching for either name are looking at the same Sanofi compound studied in head and neck cancer and lung cancer trials.

How many patients were enrolled in tirapazamine trials?

The tirapazamine Phase 3 program enrolled patients across its studies, including 861 participants in NCT00094081 and 317 participants in the TRACE trial, NCT00174837. The trials were randomized and conducted in adults aged 18 years and older, with enrollment recorded across multiple countries.